Scottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)

ISRCTN ISRCTN32884890
DOI https://doi.org/10.1186/ISRCTN32884890
Secondary identifying numbers HTA 94/24/03
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
10/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr John Keating
Scientific

Department of Orthopaedics
University of Edinburgh
Royal Infirmary
Little France
Old Dalkeith Road
Edinburgh
EH16 4SU
United Kingdom

Phone +44 (0)131 242 3436
Email johnkeating@ed.ac.uk

Study information

Study designProspective randomised multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleScottish Trial of Arthroplasty or Reduction for Subcapital fractures (STARS)
Study acronymSTARS
Study objectivesIn a prospective randomised multicentre trial we will evaluate the management of displaced subcapital fractures in fit elderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation. The trial will be conducted under the auspices of the Scottish Orthopaedic Trial Network, which involves the four university orthopaedic centres and associated district general hospitals. Patients will be randomised to one of three treatment groups and will be followed up for a minimum of two years.

Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2000 to 31/08/2002.
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedInjury, occupational diseases, poisoning: Musculoskeletal injury
InterventionThere are three treatment options:
1. One method of mending the break is with a type of screw, sometimes with a plate on its side; the two parts of the bone are joined together, and no bone is replaced.
2. A second method using a hip replacement. The ball at the end of the femur bone is replaced by an artificial 'ball' which is fixed into the top of the rest of the femur bone; the socket is not replaced.
3. The third method is also a type of hip replacement. Like the second method, the ball of the femur is replaced, but the socket in the hip bone is also replaced.
Intervention typeOther
Primary outcome measureClinical outcome will include perioperative mortality and reoperation. Functional outcomes will be assessed using a hip rating questionnaire and the EuroQoL functional outcome questionnaire. A cost-effectiveness and cost utility analysis will be integrated into the study protocol.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/06/1996
Completion date31/08/2002

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participants298
Total final enrolment298
Key inclusion criteriaElderly patients with bipolar hemiarthroplasty, total hip arthroplasty or reduction and fixation.
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/06/1996
Date of final enrolment31/08/2002

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Orthopaedics
Edinburgh
EH16 4SU
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2005 Yes No

Editorial Notes

10/07/2019: Total final enrolment added.